Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325 - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00807937

Purpose

The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.

Condition	Intervention	Phase
Anxiety Disorders	Drug: AZD7325 Drug: Lorazepam Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups of AZD7325, With a Lorazepam Arm, in Subjects With Generalized Anxiety Disorder (GAD)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Lorazepam

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization

Secondary Outcome Measures:

Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder.

Change: score at week 4 minus score at randomization
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.

Change : percentage at week 4 minus percentage at randomization

Enrollment:	369
Study Start Date:	December 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A AZD7325 5mg twice daily	Drug: AZD7325 4 tablets and 1 capsule taken twice a day for 28 days
Experimental: B AZD7325 15mg twice daily	Drug: AZD7325 4 tablets and 1 capsule taken twice a day for 28 days
Active Comparator: C Lorazepam 2mg twice daily	Drug: Lorazepam 4 tablets and 1 capsule taken twice a day for 28 days
Placebo Comparator: D Placebo	Drug: Placebo 4 tablets and 1 capsule taken twice a day for 28 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent before any study-related procedures start.
The patient is previously diagnosed with Generalized Anxiety Disorder.
The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.

Exclusion Criteria:

Patient has a lifetime history of schizophrenia or other psychotic disorders
Patient has a history of seizures or seizure disorder.
Patient is pregnant or breast feeding.
Patient has received electroconvulsive treatment (ECT) in the past.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807937

Show 51 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Mark A. Smith, MD, PhD

AstraZeneca

More Information

No publications provided

Responsible Party:	Mark A. Smith, MD PhD, Medical Science Director, Emerging Psychiatry, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00807937 History of Changes
Other Study ID Numbers:	D1140C00014
Study First Received:	December 12, 2008
Results First Received:	July 29, 2010
Last Updated:	September 16, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Generalized Anxiety Disorder
GAD
Anxiety

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents

Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012